Cambridge Healthtech Institute's 27th International

Biodetection Technologies

Point-of-Care for Biodefense

June 18-19, 2019

The development of bioanalytical devices that are portable, compatible, scalable and reliable is critical to effective biodefense at the point-of-care. In addition, clinical data must be generated and incorporated into the key operational decision-maker
networks. Cambridge Healthtech’s 27th International Biodetection Technologies: Point-of-Care for Biodefense will bring together the global industry, academic and government biodefense community to discuss advancements in approaches for optimizing
performance of field technologies, translational challenges, regulatory approval of diagnostic tools, and data analysis to enable effective decision-making.

This event is in conjunction with our 27th International Biodetection Technologies: Biothreat and Pathogen Detection, as well as our 8th Annual Biosurveillance Integration conferences. Together, these events will provide three full days of programming
around biodetection technologies and biosurveillance in both the field and the lab.

Based on the proven concept of the hospital trains used for mass casualty management during the first two World Wars, the concept for an all hazards “disaster train” is outlined to illustrate a new approach to consequence management of a large-scale
biological incident.

Starting in 2007, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), established a network of centers to enhance the progression of promising technologies to the commercial market. The Johns Hopkins Center for Point of Care Tests
for Sexually Transmitted Diseases is one of those centers. It provides resources to industry and organizations at no charge to speed the progression of promising technologies to commercialization. These resources include technology comparisons, access
to physicians and other end users, de-identified clinical samples, implementation guidance, critical path funding and other resources to help companies reach the market faster.

2:30 How to Support Biodefense Policies with Solid Evidence-Based Fact? Lessons Learned from EU Policies that Required Solid Evidence-Based Facts

Any policy intervention/action/decision ought to be based on solid, evidence-based scientific facts that have been analysed with adequately validated reference methodologies. The presentation will provide examples on how this challenge is approached in
EU on other health-related EU policies, as a baseline of knowledge that might inspire the challenge on how to efficiently and globally coordinate efforts for biothreat and pathogen detection in support to biodefence policies.

3:00 Hospital Acquired Infections as a Threat to Public Health and Global Security

The deliberate exploitation of naturally occurring infectious micro-organisms and release into vulnerable sub-populations constitutes a global catastrophic biological risk. Of specific concern is the intentional release of such organisms in a manner that
would elicit a burden of disease above and beyond the capabilities of available medical countermeasures. Consequences include increased morbidity, mortality, anxiety, societal instability, economic burden, and disruption of global security. Pediatric,
geriatric and immune-compromised patients are at a higher risk for hospital acquired infections (HAIs). We present and discuss risk factors for acute care neonatal, pediatric, and geriatric HAIs. This information is crucial for determining resource
needs for biothreat detection and mitigating risk which, in turn, strengthen preparedness.

Vaccination is one of the most effective ways to control influenza outbreaks and protect animal and public health. Newcastle disease virus (NDV)-based influenza vaccines have been demonstrated to be efficacious and safe in poultry. Herein, we developed
an NDV-based H5 vaccine (NDV-H5) that expresses a codon-optimized ectodomain of the hemagglutinin from an H5N2 virus and evaluated its efficacy in chickens. Results showed that both live and inactivated NDV-H5 vaccines completely protected chickens
from lethal challenge with a highly pathogenic H5N2 virus.

Our newly developed anthrax vaccine has proven efficacious with only three doses of vaccine required for adults and children based on pre-clinical studies with approximately 3 doses over three months as compared to currently licensed anthrax vaccine which
requires 6 doses over 6 months.

5:15 End of Day & Dinner Short Course Registration*

6:00 Dinner Short Courses

SC1: Sample Preparation Technologies for Pathogen Detection

Instructor: Dave Alburty, CEO, InnovaPrep LLC

This tutorial will discuss sample preparation technologies for detection, identification and analysis of biomedical, biological and chemical agents, biothreats in point-of-care, laboratory and field settings. It will review the novel and rapid technologies
for sample preparation, application of analytical strategies and automation in biodetection.

Extending the concepts of innate immune recognition to the laboratory can allow for universal diagnostics. We have been working on this premise for a decade, facing three major challenges - 1) detection on amphiphiles signatures, 2) sensitive diagnostic
platforms, and 3) engineering portable and automated systems. This presentation will cover a description of the development so far and clinical data demonstrating our sensor and approach.

We present here a series of advances in portable nucleic acid amplification testing by interfacing our QUASR RT-LAMP assay detection with a consumer class smart phone that both controls simple assay hardware, and performs assay analysis and scoring. The
resulting system breaks conventional barriers of differential diagnostics by directly detecting multiple viral targets from crude human samples, including Zika, chikungunya, and dengue viruses, and providing proof of concept for a new generation of
fast, affordable, and portable diagnostic tools.

In this talk we demonstrate that a multiplexed, hybridization-based RNA detection platform, NanoString, can be used for accurate and sensitive broad-range bacterial detection from crude lysates and primary clinical samples through rRNA detection, with
identification of known and phylogenetic classification of unknown organisms. We also show that transcriptional signatures of antibiotic response can be used for phenotypic antibiotic susceptibility testing (AST) on the same RNA detection platform,
with simultaneous measurement of key genetic resistance determinants in the same assay.

10:50 Point-of-Care Radiation Biodosimeter for Triage Following a Nuclear Event

Kathryn Todd, PhD,
Associate Laboratory Director, SRI International

The Biomedical Advanced Research and Development Authority (BARDA) has funded SRI International (SRI) under Contract HHSO100201700030C to develop a point-of-care (POC) radiation biodosimeter for use as a triage medical device in the case of a nuclear
event in an urban setting, where approximately 1M individuals may be exposed to ionizing radiation. This presentation will discuss the system concept, development, and validation strategy of SRI’s POC radiation biodosimeter. We will also address
the unique challenges of pursuing regulatory clearance for a POC triage radiation biodosimeter.

11:30 Apolipoprotein H as a Sensor-Scavenger Protein Tool To Concentrate Pathogens For Their Early and Ultrasensitive Diagnostic To Improve Surveillance And/Or The Healthcare Mitigation

Francisco Veas, PhD, Professor, French Research Institute for Development (IRD); Head of the Comparative Molecular Immuno-Physiopathology Lab, French Ministry of Defense

Soon upon a homeostasis disruption of a given organism, due to trauma, autoimmune attack, or infection, the innate acute phase immune response is rapidly activated to restore the homeostatic profile. We have shown that ApoH is not only able to interact with multiple pathogens including enveloped or non-enveloped viruses and Gram-positive or -negative bacteria but also using ApoH-coated paramagnetic beads, we have developed methods to allow a very early and ultrasensitive detection (beyond the PCR limits) of multiple clinical or native blood-borne, water-borne air-borne, food-borne, nosocomial viruses and bacteria.

12:00 PM Enjoy Lunch on Your Own

Advances in Fieldable Technologies and Assays

1:40 Chairperson’s Remarks

Steven Hatfill, PhD, Adjunct Assistant Professor, Division of Clinical Research and Leadership, George Washington University School of Medicine

1:45 Same Day, Single Assay Identification of Seasonal and Emerging Influenza Viruses with FluChip-8G Insight

Amber Taylor, R&D Manager, Molecular Diagnostics, InDevR Inc.

FluChip-8G Insight is a microarray-based molecular assay that provides same day subtyping of seasonal and nonseasonal influenza A viruses and lineage differentiation of influenza B viruses in a single, multiplexed assay with automated data interpretation.
The FluChip-8G Insight assay is a powerful tool for influenza surveillance that provides same day identification of potentially pandemic influenza A while also providing detection and differentiation of seasonally circulating influenza viruses.

2:15 Physiological Models of the Most Potent Poison: Acute and Chronic Animal Models of Respiratory Botulism

Patrick
McNutt, Principal Investigator, U.S. Army Medical Research Institute of Chemical Defense, USAMRICD

Botulinum neurotoxins (BoNTs) are a family of neuroparalytic proteins expressed by members of the Clostridium genus of anaerobic bacteria. Collectively, the BoNTs are the most poisonous substances known. Here we present new animal models to study
the progression and reversal of respiratory botulism with high resolution and use these models to demonstrate treatment strategies that effectively restore respiratory function in animals exposed to sublethal and lethal doses of botulism.

We have discovered and continue to explore silica-based hybrid materials that have been successfully used for biomolecule and living cell stabilization. This sample stabilization medium addresses significant challenges faced by far-forward military
personal. Rapid in-field detectors can provide preliminary analysis of biosamples, but subsequent testing for validation or forensic analysis may be necessary. Safe and secure collection and stabilization of biological samples would allow
for accurate biosample identification, ensuring proper treatments are received. Further, allowing transport of biosamples from resource-limited regions to a modern bioanalytical laboratory would prove invaluable in identification of emerging/unknown
biothreats.

Draper has developed a diagnostic platform technology for rapid bacterial Identification and Antibiotic Susceptibility Testing (IDAST) utilizing engineered bacteriophage probes that produce light upon successful infection of a bacterial host.
To date, this “lumiphage” technology has targeted clinical applications, where rapid (<2 hours) identification of infecting agents and their antibiotic susceptibility profiles is urgently needed to combat the growing antimicrobial
resistance (AMR) problem. Approaches to bacterial diagnostic testing using bacteriophages will be discussed as well as a potential application for airborne bacterial threat detection.